A Multicenter Breast Cancer Biospecimen Registry

NCT ID: NCT02712645

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Brief Summary

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This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Females of all racial and ethnic groups who are 40 years or older.
2. Women must:

1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
2. be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.

Exclusion Criteria

1. Inability to sign informed consent.
2. More than one radiological finding.
3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
4. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
5. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
6. Received any experimental therapeutic treatment during the previous 3 months.
7. Received any blood product transfusion within the previous 3 months.
8. Use of illegal drugs during the previous 3 months.
9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Luminist, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Redding, California, United States

Site Status RECRUITING

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Storm Stillman

Role: CONTACT

Will Olsen

Role: CONTACT

Other Identifiers

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LUM-BC-1.0

Identifier Type: -

Identifier Source: org_study_id

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